Evidence map›Paper›PMID 41605945›Full record

Trial reportNature communications2026

Dalpicilib combined with cetuximab in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma: A phase II trial.

Houyu Ju, Yunteng Wu, Chaoji Shi, Ronghui Xia, Hao Song, Xuhui Ma, Yang Liu, Lulu Sun, Ling Zhu, Lingyan Chen and 4 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05721443 (Cetuximab Plus Dalpicilib in the Second-line Treatment of Patients With HPV Negative, PD-1 Resistant Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05721443 phase2completednot on this map

Cetuximab Plus Dalpicilib in the Second-line Treatment of Patients With HPV Negative, PD-1 Resistant Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: an Open-label,Single Arm,Phase 2 Trial

TypeinterventionalSponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityRan2022 to 2025Enrolled28ConditionsRecurrent/Metastatic Head and Neck Squamous Cell CarcinomaArmsDalpiciclib+cetuximab
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Houyu Ju *Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China.
Yunteng Wu *Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China.
Chaoji Shi *Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China.
Ronghui XiaShanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology; National Clinical Research Center of Stomatology, Shanghai, PR China.
Hao SongDepartment of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China.
Xuhui MaDepartment of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China.
Yang LiuDepartment of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China.
Lulu SunDepartment of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China.
Ling ZhuShanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology; National Clinical Research Center of Stomatology, Shanghai, PR China.
Lingyan ChenClinical Research Unit, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China.
Shuyang SunDepartment of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China.
Yue HeDepartment of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China. william5218@126.com.
Guoxin RenDepartment of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China. renguoxincn@sina.com.ORCID 0000-0003-0231-4938
Jingzhou HuDepartment of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, PR China. huyayi@shsmu.edu.cn.

Funding

Clinical Research Special Project of the Shanghai Municipal Health CommissionNational Natural Science Foundation of ChinaShanghai Jiao Tong University School of Medicine
6 · The paper itself

Abstract

Human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC) is characterised by hyperactivation of the cyclin-dependent kinase 4/6 (CDK4/6) pathway. As immunotherapy has become the first-line treatment for HNSCC, resistance to anti-programmed death-1 (PD-1) agents has emerged as a pivotal challenge. This prospective, single arm, phase II study (NCT05721443) evaluated the efficacy and safety of dalpiciclib, a CDK4/6 inhibitor, combined with cetuximab in patients with anti-PD-1-resistant, HPV-negative recurrent and/or metastatic HNSCC. Patients diagnosed with p16-negative R/M HNSCC resistant to first-line anti-PD-1 therapy without prior cetuximab treatment were enroled. Patients received oral dalpiciclib (150 mg daily on days 1-21 of each 28-day cycle) and intravenous cetuximab (400 mg/m

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCetuximabHead and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckAdultAgedDrug Resistance, NeoplasmFemaleHumansImmune Checkpoint InhibitorsMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProgrammed Cell Death 1 ReceptorProspective StudiesCetuximabImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 Receptor

Identifiers

PMID41605945
PMCPMC12953782

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.